Genprex to Present at NobleCon16 Investor Conference

On February 3, 2020 Genprex, Inc.("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company utilizing a unique, non-viral proprietary platform designed to deliver tumor suppressor genes to cancer cells, reported the Company will present at the Noble Capital Markets 16th Annual Investor Conference on Monday, February 17, 2020 at 1:30 p.m. EST (Press release, Genprex, FEB 3, 2020, View Source [SID1234553779]). The conference is being held on February 16-18, 2020 at the Seminole Hard Rock Hotel & Casino in Hollywood, Florida.

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Event: NobleCon16 – Noble Capital Markets’ 16th Annual Investor Conference

Presentation Date: Monday, February 17, 2020

Presentation Time: 1:30 p.m. EST – Terrace Ballroom A

Location: Seminole Hard Rock Hotel & Casino – Hollywood, FL

Mr. Rodney Varner, Chief Executive Officer of Genprex, will deliver an overview of the Company and provide updates on its product pipeline, including the recent Fast Track Designation received from the Food and Drug Administration for its Oncoprex immunogene therapy in combination with AstraZeneca’s Tagrisso. To arrange a one-on-one meeting with the Company, please email [email protected].

A high-definition video webcast of Mr. Varner’s presentation will be available for playback at the link below approximately 24 hours following his live address, and it will be archived for 90 days following the conference:

Presentation Webcast Playback: http://bit.ly/2S5AR7Z

This is the 16th year Noble Capital Markets has hosted "NobleCon" and has invited emerging growth companies to present to and meet with attending investors. NobleCon will feature approximately 125 small growth companies presenting across four tracks and will be broadening access to investors worldwide by hosting the conference site on Channelchek.com, its web-based market platform that emphasizes emerging growth companies.

Catalent To Acquire Leading Cell Therapy Company MaSTherCell Global for $315 Million, Creating an Industry-Leading Cell & Gene Therapy Platform

On February 3, 2020 Catalent, Inc. (NYSE: CTLT), the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products, and MaSTherCell Global, Inc., a technology-focused cell and gene therapy contract development and manufacturing organization to leading cell therapy innovators, reported that Catalent has agreed to acquire MaSTherCell Global, a company backed by Great Point Partners, SFPI-FPIM, and Orgenesis Inc. (NASDAQ:ORGS), for an aggregate of $315 million in cash, subject to a customary adjustments (Press release, Catalent, FEB 3, 2020, https://www.catalent.com/catalent-news/catalent-to-acquire-leading-cell-therapy-company-masthercell-global/ [SID1234553778]).

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"MaSTherCell extends our leadership position in the biotech industry, complements our leading gene therapy offering, and allows us to deliver comprehensive development, manufacturing, analytical, fill-finish, and clinical supply solutions for innovators across the large molecule space," said John Chiminski, Catalent’s Chair & Chief Executive Officer. "Both autologous and allogeneic cell therapies provide important new treatment options, with a rising number expected to gain regulatory approval over the coming years. Catalent is well-positioned to combine MaSTherCell’s expert teams and capabilities with our extensive resources and experience in scaling new platforms, and to help MaSTherCell build-out its development and commercial manufacturing capabilities."

Founded in 2011, MaSTherCell has a 25,000 square-foot facility in Gosselies, Belgium providing clinical services, and construction is in progress on a dedicated 60,000 square-foot adjacent commercial-scale production and fill-finish facility, which is scheduled to open in the fall of 2021 and ultimately add over 250 new jobs to the current team of over 240. Its 32,000 square-foot U.S. facility in Houston, Texas, upon completion of validation activities, will focus on development-scale projects and will employ a team of over 50 experts before the end of the year. MaSTherCell has a growing customer base and offers a unique portfolio of capabilities and technologies that include the development and manufacture of autologous and allogeneic cell therapies, as well as a variety of related analytical services. Its experience includes therapies based on chimeric antibody receptor-engineered T cells (CAR-T), T cell receptors (TCR), tumor-infiltrating lymphocytes (TIL), and mesenchymal stem cells (MSC).

Darren Head, MaSTherCell’s Chief Executive Officer, commented, "MaSTherCell has built comprehensive capabilities to address the complexities of cell therapy production. Like Catalent, our experience has taught us the importance of technology selection, advanced know-how, and quality and regulatory expertise for successful cell therapy programs that are aimed at producing life-altering treatments. We are excited to join the industry-leading team at Catalent and work together to scale-up our business. This combination will strengthen our service offering to our customers and, in the end, benefit patients who need innovative life-saving therapies. Catalent’s backing will position MaSTherCell for growth and enhance Catalent’s existing presence in Belgium."

Vered Caplan, Chief Executive Officer of Orgenesis, stated, "We are very proud of the developments and accomplishments at MaSTherCell, which has become a best-in-class contract development and manufacturing organization (CDMO) servicing many of the leading cell and gene therapy companies. Since we completed our acquisition of MaSTherCell in 2015, the business has grown along with this burgeoning industry. With Catalent’s expertise and resources, we believe MaSTherCell will be well positioned to continue on its current trajectory in order to meet the evolving needs of the industry."

Noah Rhodes, Managing Director at Great Point Partners, commented, "We identified MaSTherCell as the leading provider of development and manufacturing services to cell and gene therapy companies, and have enjoyed watching the company and its team continue to flourish. We cannot think of a better partner for MaSTherCell than Catalent, as the combined company will be a leading vertically-integrated provider able to serve customers and patients on a global basis."

Upon completion of the transaction, which is expected in the current, third quarter of Catalent’s 2020 fiscal year and is subject to customary closing conditions, MaSTherCell’s 240 talented employees, including its outstanding leadership team, will become part of the Catalent Biologics business.

The acquisition is an all-cash transaction, which Catalent expects to finance with either a partial drawn down of its revolving credit facility or the proceeds from future capital-raising activity. As part these activities, Catalent has obtained $200 million of committed financing, subject to customary conditions, from JPMorgan Chase Bank N.A. It should be noted, however, that the agreement governing the acquisition is not contingent on any financing activity. Catalent intends to file a Current Report on Form 8-K with the Securities and Exchange Commission, which will have further details concerning the acquisition and the committed financing.

Boston Pharmaceuticals Appoints Dr. Craig T. Basson, M.D., Ph.D., as Chief Medical Officer

On February 3, 2020 Boston Pharmaceuticalstoday reported the appointment of Dr. Craig T. Basson, M.D., Ph.D., as Chief Medical Officer (Press release, Boston Pharmaceuticals, FEB 3, 2020, View Source [SID1234553777]). Previously, Dr. Basson was Global Head of Translational Medicine (Cardiovascular and Metabolism) at Novartis for 10 years, where he led the team developing new global programs to translate basic findings into novel therapeutics.

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"As a highly-regarded scientist and drug developer, Craig’s experience in global translational medicine is uniquely suited to Boston Pharmaceuticals as we continue to evolve our pipeline," said Robert Armstrong, Ph.D., Chief Executive Officer and Co-Founder of Boston Pharmaceuticals. "His proven track record for innovation and drug development will support our mission of addressing unmet medical needs for larger patient populations."

"Boston Pharmaceuticals’ strategy of following the data and selectively advancing a portfolio of high value candidates into differentiated therapeutics excites me," said Dr. Basson. "I am thrilled to join Boston Pharmaceuticals at this time of important growth for the company and look forward to leveraging my experience to accelerate the development of the pipeline and to continuing to bring novel medicines to patients in need."

Dr. Basson was previously Global Head of Translational Medicine for the Cardiovascular and Metabolic Therapeutic Areas at Novartis Institutes for Biomedical Research. At Novartis, he co-led the Cardiovascular Metabolism (CVM) Disease Area Decision Board, oversaw the leadership of early clinical portfolio through Proof of Concept (PoC) and supported late phase clinical programs by indication expansion PoC studies and specialized clinical pharmacology and profiling studies. He has been involved in the development of a number of important and novel medicines for patients with cardiovascular disease, diabetes, and metabolic disorders.

Prior to Novartis, Dr. Basson was a Professor of Cardiology and Internal Medicine at Cornell University Medical College. He obtained an M.Sc. in Physiological Sciences at the University of Oxford and completed an M.D. and Ph.D. at Yale University. Dr. Basson serves as a scientific advisor to variousfor-profit and nonprofit organizations.

Calibr’s ‘switchable’ CAR-T platform for cancer moves forward with FDA clearance of Investigational New Drug application

On February 3, 2020 Calibr, the drug discovery and development division of Scripps Research, reported that the U.S. Food and Drug Administration has given clearance to the Investigational New Drug (IND) application for Calibr’s "switchable" CAR-T cell therapy, which is being evaluated for the treatment of certain cancers, including relapsed/refractory B-cell malignancies such as non-Hodgkin lymphoma and chronic lymphocytic leukemia (Press release, The Scripps Research Institute, FEB 3, 2020, View Source [SID1234553776]).

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Having achieved this regulatory milestone, Calibr can begin clinical trials for its novel cell therapy candidate, CLBR001 + SWI019. The therapy leverages a patient’s own immune cells to treat cancer, putting them under the control of a novel molecular "switch" that seeks to eliminate life-threatening side effects that have hampered the use of cell therapies to date.

"CLBR001 + SWI019 is a first-in-class switchable CAR-T cell platform designed to confer the efficacy associated with engineered T cell therapies, while potentially affording greater safety and versatility through the incorporation of a control switch," says Travis Young, PhD, Calibr’s vice president of biologics and leader of its CAR-T development program. "If successful, this approach holds promise to be universally applied to other types of cancer, including solid tumor cancers that have yet to reap the benefits of CAR-T therapies."

CAR-T, short for chimeric antigen receptor T-cell, is a relatively new form of cancer therapy that has achieved remarkable responses in patients with blood- or bone marrow-based diseases such as leukemias and lymphomas. It works by genetically engineering a patient’s own T cells—which play a key role in immune response—to seek and destroy cancer within the body. However, some patients who receive T-cell therapies experience an adverse effect, which can be severe, called cytokine release syndrome, which occurs when the immune system reacts too strongly and causes dangerous inflammation.

Calibr’s switchable CAR-T cell platform incorporates an antibody known as SWI019 that acts as a switch, activating the engineered cell and directing it to engage the cancer target. This may allow doctors to more precisely regulate the potency of the therapy and is expected to provide a significant safety advantage. In preclinical studies, the approach proved highly effective at eliminating tumors while controlling the level of cytokines produced in response to treatment.

"AbbVie continues to be impressed by Calibr’s progress on advancing this innovative switchable cell therapy technology," says Mohit Trikha, Ph.D., vice president, head of Oncology Early Development and Bay Area site head at AbbVie. "This milestone is an important step forward for this potential CAR-T therapy and our recently expanded collaboration with Scripps Research, which holds promise to rapidly advance additional treatment options for patients."

The launch of the clinical study—the third being run independently by the institute and the fifth study to originate from Calibr’s research—is another major landmark for Scripps Research’s pioneering nonprofit drug development model. News of the FDA’s decision comes on heels of another recent IND acceptance for Calibr’s first-in-class bispecific antibody for prostate cancer; that drug candidate, CCW702, is now being tested in a phase I trial for patients with metastatic, castrate resistant prostate cancer.

The switchable CAR-T cell platform was invented at Scripps Research and progressed to the Investigational New Drug stage with support from the Wellcome Trust. Calibr recently partnered its platform with biopharmaceutical company AbbVie, which holds certain rights to commercialization.

"AbbVie has been an outstanding partner for Scripps Research on this CAR-T cell program," says Scripps Research President and CEO Peter Schultz, PhD. "We look forward to continuing to bring novel therapies to the clinic through this collaboration."

Clinical development of CLBR001 + SWI019 will be led by Calibr’s Chief Medical Officer Pamela D. Garzone, PhD. Calibr expects to begin enrolling patients for the phase 1 clinical trial in the first half of 2020, with the potential to expand the platform to solid tumors in coming years.

Study demonstrates liquid biopsy as effective predictor of stage III melanoma relapse and treatment

On February 3, 2020 The University of Texas MD Anderson Cancer Center reported that circulating tumor cells (CTCs), a form of liquid biopsy, was independently associated with melanoma relapse, suggesting CTC assessment may be useful in identifying patients at risk for relapse who could benefit from more aggressive therapy following primary treatment (Press release, MD Anderson, FEB 3, 2020, View Source [SID1234553774]).

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Results from the study were published in Clinical Cancer Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper). Although CTCs can be detected in melanoma patients, there is limited data regarding their significance in stage III (node-positive) disease. This prospective study was based on earlier research that found CTCs in a significant number of breast cancer patients, which was associated with relapse, independent of other existing methods for determining prognosis.

"Our findings are significant, given that there is a need for blood-based biomarkers to guide clinical decision making for stage III melanoma patients," said Anthony Lucci, M.D., professor of Breast Surgical Oncology and Surgical Oncology, and study lead. "There currently are no blood tests available to help doctors accurately tell which patients are likely to relapse, and should be given therapy, and which are low risk, and could be observed."

The researchers assessed CTCs during the patient’s first clinic visit, and relapse-free survival was compared between patients with one or more CTCs, versus those with no CTCs. CTCs were observed in 90 out of 243 patients enrolled in the study.

"Our analysis demonstrated that CTC detection was significantly associated with a decrease in relapse-free survival at six months, and persisted at a 54-month longer-term follow-up," said Lucci. "The data from this study provides support for the future pursuit of liquid biopsy techniques to help identify patients most likely to benefit from adjuvant systemic therapy."

Lucci added that this is vital given that there currently is no clear consensus on when to recommend immunotherapy for node-positive melanoma patients. Despite the development of new targeted and immune therapies to treat melanoma, many patients either do not respond to these therapies or develop resistance to therapy within six to eight months. Because such therapies also can have side effects, avoiding treatment in patients at low risk for relapse may prevent overtreatment.

The study was funded by Sheila Prenowitz, Debbie and Craig Kiefer, the Simon and Linda Eyles Foundation, the Sam and Janna Moore family, and the Wintermann Foundation. Lucci reported no disclosures.